Statements and Speeches

Mark-up of Medical Device Legislation
October 2, 2002

By Henry A. Waxman

The medical device bill before us represents a hard-fought compromise and I commend the majority for their tireless efforts to craft bi-partisan legislation on a contentious topic. You can be sure that it wasn't easy to gain my support for a bill that includes a program to partially privatize inspections of medical device plants.

Overall, I believe that the bill will benefit the public by providing the FDA with some desperately needed resources for review of new medical devices. A user fee program, similar to the one we put in place for the FDA review of new drugs, should serve the public health by improving the timeliness and the quality of the FDA's review of medical devices. And I am hopeful that new provisions on reuse of medical devices will improve the safety of this practice without driving up the cost of health care.

But while I support this bill on balance, I still have doubts about the wisdom of some of its provisions. I am concerned that we have not required, as we did with prescription drug user fees, that a defined portion device user fees be used to track the safety of medical devices after approval. When we speed up approvals of medical products, we owe it to our citizens to make sure that these products are watched for safety problems after approval. The bill does, however, include an increased authorization for postmarket surveillance of devices, and this is a good start.

I also remain concerned about allowing device manufacturers to pay private parties to carry out required inspections of their plants, rather than be inspected by the FDA. Paying third parties to certify compliance with federal law is the model that has been relied on in the accounting industry. When the model failed us in the accounting realm, people lost their savings and their jobs. If it fails us in the health realm, the results may be even more tragic.

Because we know that the risks are high, we need to be doubly careful that the use of private inspectors does not result in inappropriate financial relationships and biased inspections. The majority has responded to my concerns by giving the FDA some authority to say "no" to a manufacturer's selection of a specific private inspector. I believe that the bill would be stronger and would offer greater protection to consumers if it went further and authorized FDA to assign inspectors in the first instance, while taking account of the manufacturer's needs.

If it were up to me, the FDA would be given sufficient resources to carry out its review and inspection responsibilities without needing to rely on either user fees or delegation of its responsibilities to private parties. I recognize, however, that the FDA has not received sufficient resources to carry out all the responsibilities that we have given it. In the absence of adequate appropriations, the agency is not conducting required inspections in a timely manner nor meeting statutory deadlines for some device reviews. Given this reality, other means of addressing these shortfalls may be appropriate.

This bill is a very long way from being perfect. On the other hand, leaving the agency without sufficient funds to do its job is even more imperfect. Since I do not believe in letting "the best" be the enemy of "the better," I will support this compromise. The majority was willing to incorporate in the bill provisions to make sure that the successes and failures of these new initiatives will be watched. I trust that this Committee will use its oversight authority to closely monitor the impact of this legislation, making sure that we have not jeopardized the safety of medical devices.